NCT06250244

177Lu-LNC1011 in Patients with Metastatic Castration-resistant Prostate Cancer

A Dosimetry Study and Dose-escalation and of [177Lu]Lu-LNC1011 in Metastatic Castration-Resistant Prostate Cancer Patients

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study employed an open-label, non-randomized design, representing the first human trial of its kind. It utilized a standard 3+3 dose-escalation approach, focusing on patients with metastatic castration-resistant prostate cancer, initiating treatment at a dose of 1.85 GBq over a 6-week period. Subsequent cohorts underwent sequential 50% dose escalations until the observation of dose-limiting toxicity (DLT).

Detailed description

\[177Lu\]Lu-LNC1011 is a novel long-circulating PSMA therapeutic probe. This study represents the first human investigation, aiming to explore its maximum tolerated dose (MTD), safety, dosimetry, and initial treatment efficacy in patients with metastatic castration-resistant prostate cancer (mCRPC).This study employed an open-label, non-randomized design, representing the first human trial of its kind. It utilized a standard 3+3 dose-escalation approach, focusing on patients with metastatic castration-resistant prostate cancer, initiating treatment at a dose of 1.85 GBq over a 6-week period. Subsequent cohorts received a dose escalation of 0.925 GBq from the previous cohort.

Conditions

• Metastatic Castration-resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	177Lu-LNC1011	\[177Lu\]Lu-LNC1011 is a novel long-circulating PSMA therapeutic probe.

Timeline

• Start date: 2023-05-01
• Primary completion: 2025-04-01
• Completion: 2025-10-01
• First posted: 2024-02-09
• Last updated: 2024-12-11

Locations

1 site across 1 country: China